Register your device in any market, from one documentation system
Every country wants its own dossier, its own classification, its own language. Our country kits turn that maze into a repeatable method — gap analysis, essential requirements, technical file — built straight from the regulations.
Markets we cover
Three markets live today, more in preparation. Each live market has a free overview and its own kits.
Going global multiplies the paperwork, not the team
A CE technical file rarely transfers as-is. Each authority has its own essential principles, class rules, labelling language and submission format — and a single missing killer item can send you back months.
The same four steps in every market
Every step has a kit behind it. Buy the one you need, or the bundle.
A look inside the gap analysis
| ID | Requirement | Status | Evidence | EU MDR GSPR |
|---|---|---|---|---|
| EP-04 | Risk management file established and maintained | Yes | RMF-001 rev 3 | GSPR 3 |
| EP-10 | Biological evaluation for patient-contacting materialsKiller | No | — | GSPR 10.1 |
| EP-17 | Labelling and IFU supplied in the local language | Partial | Draft, EN only | GSPR 23.1 |
| EP-23 | Usability engineering file for lay users | Yes | UEF-002 | GSPR 5 |
Illustrative. Every kit ships as an Excel workbook you complete — the gate stays red until the last killer item is closed.
Kits, consultants or going it alone
Where ready-to-use documentation kits sit between doing it yourself and hiring a full consultancy — and how the two combine.
| Do it yourself | Full consultancy | MD Regulatory kits | Kits + consulting | |
| Upfront cost | Low | High | Low–moderate | Moderate |
| Speed to a draft | Slow | Moderate | Fast | Fast |
| Regulatory rigour | Varies | High | High | High |
| Expert review of your file | No | Yes | Self-service | Yes, as needed |
| You keep control | Yes | Partly | Yes | Yes |
| Reusable next time | No | No | Yes | Yes |
The last two columns are not either/or. Start with the kits, then bring us in only where you need it — a review of the completed file, a tricky classification, or the full submission. See how consulting works.
Frequently asked
Not sure which market — or want it done for you?
We can help you choose the right market and kit, review your completed file, or take on the full submission as a consulting engagement.
Pick a market and see where your file stands
Free overviews. Paid kits from €89. Instant download, no subscription.
Explore the Market Access Hub